Systems for replacing a native heart valve and aorta with a prosthetic heart valve and conduit

ABSTRACT

A medical device includes an expandable conduit, a prosthetic heart valve and a delivery device, including a balloon catheter. The expandable conduit may include one or more inner or outer sleeves supported by a frame or stent. The sleeve(s) may be a bioprosthetic tissue wrapped, molded or sewn about the frame or stent. Coupled to an end of the expandable conduit is the prosthetic heart valve. The conduit and heart valve may be crimped on the balloon catheter for percutaneous deployment. The frame may be constructed of a balloon-expandable material for the conduit portion and a self-expandable material for the prosthetic heart valve portion. The prosthetic heart valve is anchored at the native heart valve and then the conduit to be expanded into place to protect the aorta. The self-expanding prosthetic heart valve avoids the need for balloon mounting. This provides for a smaller diameter and easier delivery.

RELATED APPLICATIONS

The present application is a divisional of U.S. patent application Ser.No. 14/033,075, filed Sep. 20, 2013, which claims priority under 35U.S.C. § 119 to U.S. Provisional Application Ser. No. 61/705,495, filedSep. 25, 2012. Both U.S. patent application Ser. No. 14/033,075 and U.S.Provisional Application Ser. No. 61/705,495 are incorporated byreference in their entirety.

FIELD OF THE INVENTION

This application relates to methods, systems, and apparatuses for safelyreplacing native heart valves and aorta with prosthetic heart valves andconduits.

BACKGROUND OF THE INVENTION

Prosthetic heart valves have been used for many years to treat cardiacvalvular disorders. The native heart valves (such as the aortic,pulmonary, tricuspid and mitral valves) serve critical functions inassuring the forward flow of an adequate supply of blood through thecardiovascular system. These heart valves can be rendered less effectiveby congenital, inflammatory, or infectious conditions. Such conditionscan eventually lead to serious cardiovascular compromise or death. Formany years, the definitive treatment for such disorders was the surgicalrepair or replacement of the valve during open heart surgery.

More recently, a transvascular technique has been developed forintroducing and implanting a prosthetic heart valve using a flexiblecatheter in a manner that is less invasive than open heart surgery. Inthis technique, a prosthetic valve is mounted in a crimped state on theend portion of a flexible catheter and advanced through a blood vesselof the patient until the valve reaches the implantation site. The valveat the catheter tip is then expanded to its functional size at the siteof the defective native valve, such as by inflating a balloon on whichthe valve is mounted.

Alternatively, the valve can have a resilient, self-expanding stent orframe that expands the valve to its functional size when it is advancedfrom a delivery sheath at the distal end of the catheter.

Balloon-expandable valves are commonly used for treating heart valvestenosis, a condition in which the leaflets of a valve (e.g., an aorticvalve) become hardened with calcium. The hardened leaflets provide agood support structure on which the valve can be anchored within thevalve annulus. Further, the catheter balloon can apply sufficientexpanding force to anchor the frame of the prosthetic valve to thesurrounding calcified tissue.

Often, heart valve problems, such as calcification, are associated withother heart problems such as aortic aneurysms. Although the deliverytechniques described above address heart valve deficiencies to someextent, less invasive approaches to other heart problems are alsodesired. It would be particularly advantageous to be able to addressboth valve and aorta problems with a minimally invasive approach.

SUMMARY

A medical device for use in a heart having a native heart valve and avessel extending therefrom is disclosed. The medical device includes aballoon-expandable conduit and a prosthetic valve. The delivery systemincludes a catheter having a balloon that is disposed inside theballoon-expandable conduit. The prosthetic valve is coupled to an end ofthe balloon expandable conduit. The prosthetic valve includes aself-expandable material configured to expand in a radially outwarddirection to frictionally engage at least a portion of the native heartvalve. The frictional engagement prevents axial movement of theprosthetic heart valve and the balloon-expandable conduit relative tothe native heart valve.

The balloon-expandable conduit may include a balloon-expandable tubularframe and a sleeve extending along and against the balloon-expandableframe. The self-expandable material may include a self-expandabletubular frame. The prosthetic valve may include valve leaflets supportedwithin the self-expandable tubular frame. The balloon-expandable tubularframe and self-expandable tubular frame may be contiguously formed of anitinol alloy. The self-expandable tubular frame may have an expandedmemory shape.

The prosthetic valve may include an annular ring of woven materialcoupling the valve leaflets to the self-expandable tubular frame.

The sleeve may be formed of a bioprosthetic tissue. For example, thebioprosthetic tissue may include a bovine pericardium, a porcinepericardium or an allogenic or autogenic collagen matrix tissue. Thebioprosthetic tissue sleeve may be glycerolized to facilitate drystorage.

The sleeve may also include a coating, such as a polymer or gel coating.

The medical device may also include a retractable sheath that defines aninterior portion. The retractable sheath holds the prosthetic valve in aradially compressed configuration. The retractable sheath may includeone or more radiopaque markers on its outer surface.

The balloon expandable material may be a plastically deformable metalmaterial such as a stainless steel or nitinol.

Also included in the medical device may be one or more anchors. Theanchors are coupled to and extend radially from an outer surface of themedical device. For example, the anchors may be supported by theballoon-expandable conduit or the self-expandable prosthetic valve. Theanchors may include structure that facilitates tissue ingrowth, such asbeads, dimples or fenestrations. The anchors may circumferentiallyspaced about the outer surface of the medical device.

A method includes delivering a balloon-expandable conduit coupled to aself-expandable prosthetic heart valve into a vessel extending from anative heart valve. Also, the self-expandable prosthetic heart valve isdelivered into the native heart valve. The method also includesinflating a balloon disposed within the balloon-expandable conduit suchthat an outer surface of the balloon expandable conduit is urged towardthe vessel. The self-expandable prosthetic heart valve is expandedwithin or near the native heart valve by axially moving a retractablesheath.

The delivering method may also include engaging the vessel or nativeheart valve with anchors coupled to the conduit or prosthetic heartvalve.

A method of assembling a medical device includes coupling aself-expandable prosthetic heart valve adjacent a balloon-expandableconduit. Also, the method includes disposing a balloon and ballooncatheter within an interior portion of the balloon-expandable conduit.The method further includes compressing the balloon-expandable conduitand the self-expandable prosthetic valve radially inwardly. The methodalso includes disposing at least the self-expandable prosthetic valveinto an interior portion of a retractable sheath.

Coupling the self-expandable prosthetic heart valve adjacent theballoon-expandable conduit may include forming a contiguous frame,coupling a bioprosthetic sleeve to at least one end of the frame andvalve leaflets to the other end of the frame. The other end of the frameis then formed to have an expanded memory shape.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a medical device including transapicaldelivery of a coupled conduit and valve with the conduit being balloonexpanded into an aorta;

FIG. 2 is a partial sectional view showing a bioprosthetic sleeveextending over a stent frame holding an expandable tissue valve;

FIG. 3 is a sectional view of a delivery catheter holding a coupledballoon-expandable conduit and self-expanding valve;

FIG. 4 is a perspective view of the medical device of FIG. 1 with thevalve self-expanding into frictional engagement with a native heartvalve to anchor the coupled conduit; and

FIGS. 5-8 are enlarged schematics of various anchors that can be coupledto outer surfaces of the medical device for improved anchoring intonative tissues.

DETAILED DESCRIPTION

Implementations of the present disclosure now will be described morefully hereinafter. Indeed, these implementations can be embodied in manydifferent forms and should not be construed as limited to theimplementations set forth herein; rather, these implementations areprovided so that this disclosure will satisfy applicable legalrequirements. As used in the specification, and in the appended claims,the singular forms “a”, “an”, “the”, include plural referents unless thecontext clearly dictates otherwise. The term “comprising” and variationsthereof as used herein is used synonymously with the term “including”and variations thereof and are open, non-limiting terms.

The inventor has observed a need for improved methods, systems, andapparatuses for delivering expandable prosthetic heart valves andconduits in a minimally invasive manner with a delivery device having asmaller diameter. The inventor has further recognized that transvalvulartechnologies provide opportunities to repair aortic pathologies, such asin the thoracic aorta or aortic arch. Conduits to supplement or replacethe aorta may be delivered through minimally invasive routes, such astransapical or transvalvular routes.

The methods and devices described below may be used to replace nativeheart valves that have calcified leaflets associated with aorticstenosis and, at the same time, to repair defects in the aortic arch orthoracic aorta. Furthermore, the methods and devices desirably enableprecise and controlled simultaneous delivery of the prosthetic valve andthe conduit.

Disclosed below are representative embodiments of a medical device thatcan be secured within a native heart valve. For illustrative purposes,embodiments of the medical device are described as being delivered tothe aortic valve and associated aorta. It should be understood that thedisclosed medical device may be configured for use with other heartvalves that have associated conduits.

Also, a range of aortic pathologies may be addressed, such as aortic orthoracic aneurysms, aorta stenosis, or aorta/thoracic dilatation.

As shown in FIG. 1, a medical device 10 includes an expandable conduit12, a prosthetic heart valve 14 and a delivery device 16, including aballoon catheter 40. The expandable conduit 12 may include one or moreinner or outer sleeves 18 supported by a frame or stent 20. Thesleeve(s) 18 may be a bioprosthetic tissue wrapped, molded or sewn aboutthe frame or stent 20. Coupled to an end of the expandable conduit isthe prosthetic heart valve 14. For example, the prosthetic heart valvemay include a portion of the frame 20 with soft tissue valve leaflets 22sewn therein. As shown in FIG. 3, the conduit 12 and heart valve 14 maybe crimped on the balloon catheter 40 for percutaneous deployment, orsome other minimally invasive deployment approach, such as a transaorticor transapical approach.

Advantageously, the frame or stent 20 may be constructed of aballoon-expandable material for the conduit 12 portion and aself-expandable material for the prosthetic heart valve 14 portion. Asshown in FIG. 2, this allows the prosthetic heart valve 14 to first beanchored precisely at the native heart valve 24 and then, as shown inFIG. 1, the conduit 12 expanded into place to protect the ascendingaorta 26. The medical device has a length sufficient to extend from thenative aortic heart valve 24 and along the aorta at least as far as theaortic arch 26.

Also advantageously, the self-expanding nature of the prosthetic heartvalve 14 allows it to be mounted over a portion of the balloon catheter40 that does not have a balloon 28. This provides for a lower diameterand easier delivery.

The device 10, including the conduit 12, prosthetic heart valve 14 anddelivery device 16 can have multiple sizes accommodating biologicalvariation in patient valve and aorta anatomy.

The frame or stent 20, as shown in FIGS. 1-4, may be comprised of aplurality of struts 30 that are interconnected to provide a latticeconfiguration with closed cells. The frame 20 may be comprised of arange of materials, including metals and plastics. For example, theframe may be comprised of a shape memory metal, such as a stainlesssteel or nitinol (nickel-titanium) alloy. Nitinol has the advantage ofbeing able to withstand large strains and other deformations. Formingthe struts 30 for metal frames 20 may include, for example,laser-cutting a nitinol or stainless steel stock tube to form the holesbetween the struts.

The frame 20 may be constructed in parts of the same or differentmaterials and later welded, sewn or otherwise bonded together. Forexample, the balloon expandable portion of the stent 20 that makes upthe conduit 12 may be constructed of a biocompatible stainless steelmaterial cut from a stainless steel tube as described above. The latticeframe 20 formed from the stainless steel may then be mounted (with orwithout some initial expansion) over the balloon 28 for later plasticdeformation by the balloon into the expanded shape.

The prosthetic heart valve 14 portion of the stent 20 may be constructedof nitinol, expanded into a deployed shape by a balloon and then heattreated to have an expanded memory configuration. This expanded memoryconfiguration is assumed upon deployment from the delivery device 16,i.e., when a retractable outer sleeve or sheath 32 of the deliverydevice (as shown in FIG. 3) is withdrawn. After formation, both portionsof the stent frame 20 may then be attached to each other by bonding,welding or having adjacent ends sewn to each other using the holesdefined by the struts 30.

A particularly elegant solution (as shown in the figures herein) is tocut the entire frame or stent 20 out of a single tube of nitinol andthen subject the nitinol to different treatments to selectively trainaxial portions for mixed expansion. For example, the cut nitinol tubemay be partially expanded and heat treated at the prosthetic valve endto have an expanded memory shape. The remainder of the frame or stent 20could be maintained in a cooled condition to avoid imprinting a memoryshape or the memory shape may be the compressed condition. Thiscompressed condition is then overcome by large plastic deformations fromlater expansion of the balloon 28. Advantageously, forming the stent 20using differential techniques but the same monolithic materials avoidsthe need for later attachment, provides for a continuity of struts,improved structural integrity, etc.

As another alternative, the stent 20 may be entirely balloon expanded orentirely self-expanding. If entirely balloon expanded, a longer orlarger balloon 28 may be used for simultaneous expansion of the entireconduit and valve combination. However, the combination of balloon andself expanding has particular advantages as described elsewhere herein.

The sleeve 18, as shown in FIGS. 1 and 4, may extend within an innersurface of the frame 20 so as to protect the struts 30 of the frame fromadhesions, clotting and other issues occurring from interaction with theblood flowing through the device 10. Alternatively, or in addition, thesleeve 18 may extend over the outside of the frame 20 or struts 30 so asto provide a surface on which to adhere to or fill the space between theframe and the surrounding native tissues of the aorta or valve of theheart. The sleeve 18 may also extend over both the inner and outersurfaces of the stent or frame 20.

Regardless of which surfaces it covers, the sleeve 18 is configured toprovide a structure that helps to deflect and guide high pressure bloodflow through the insufficient or compressed heart valve and theaneurismal aorta. Advantageously, the sleeve 18 and/or underlying frame20 may have strategically placed openings, such as at the various branchvessels of the aorta (carotid or coronary arteries) to ensure perfusionof the heart and branch vessels.

The sleeve 18 may be constructed of a range of biological and/orsynthetic materials and be applied or attached to the frame 20 indifferent ways. The sleeve may include, for example, bioprosthetictissues such as bovine pericardium, porcine pericardium, or an allogenicand/or autogenic collagen matrix tissue. Bioprosthetic materials couldbe treated to withstand age and the environment, such as by beingglycerolized to enable dry storage and improve lubrication. Thebioprosthetic tissue could also be stored in glutaraldehyde.

As another option, polymers and gels (biological or synthetic) may beused for the sleeve 18. Non-biological polymers may be used for a solidpolymer sleeve 18 or covering, such as silicone or polyurethane. Thenon-biological polymers may also include PET, PTFE or polyester films.Plant or animal derived collagen gels are an example of biologicalpolymers or gels. Gels would generally be applied to some type of asubstrate, such as an absorbable polymer substrate, a woven polyester,or bovine collagen matrix.

The sleeve 18 may also (optionally) be composed of a known graftmaterial for treating aortic aneurysms, such as Dacron or PTFE cloth.

The sleeve 18 could also include combinations of some of theaforementioned materials. For example, the Dacron or PTFE cloth could becoated with the polymer or gel.

The different material types may be attached in different ways. Forexample, the sleeve 18, if comprised of a gel or polymer, may be appliedas coating or as a molding or extrusion onto the surfaces of the frame20. This facilitates a bonding attachment along a large portion of thesurfaces of the frame 20, with some material extending into the holesdefined between the struts 30.

The sleeve 18 may also be partially or wholly applied mechanically, suchas by wrapping or sewing onto the frame 20. For example, a cloth of thesleeve 18 could be formed into a tube around the frame 20 by use of alongitudinal stitch to attach long edges of a rectangular, flatmaterial. The same longitudinal stitch could extend between the struts30 to anchor the sleeve 18 to the stent 20.

As another option, the cloth (Dacron or PTFE) sleeve 18 may haveadditional layers applied to it such as an outer or inner coating orlayer of gel or polymer. The gel or polymer could be applied as acoating, molding or extrusion onto the cloth (before or after thecloth's attachment) to form the multiple layered sleeve 18.

The sleeve 18 may also optionally extend over the (and be consideredpart of) the prosthetic heart valve 14, as shown in FIGS. 2 and 3. Or,the sleeve 18 may terminate prior to reaching the axial end of the heartvalve 14, as shown in FIGS. 1 and 4, even leaving a gap therein tofacilitate blood flow to the coronary arteries extending from the aortanear the aortic valve root.

As shown in the cross-section of FIG. 3 and in FIG. 2, the prostheticheart valve 14 includes an axial portion of the stent 20, soft tissuevalve leaflets 22, a ring 34 and a plurality of stitches 36.

As described above, the portion of the stent 20 (or its own frame orstent if separately formed and attached) used to support the valve is aself-expanding material such as nitinol alloy with an expanded memoryshape. A free end 38 of the stent 20 may terminate in a flared,crenellated memory configuration when deployed at the native heart valve24, as shown in FIGS. 1 and 4. It takes this shape, for example, becausethere is no surrounding native tissue to constrain it from assuming thefully open memory shape. The flared shape may advantageously avoidinterfering with blood flow from the heart.

Also advantageously, the expanded portion of the stent 20 exerts aradially outward force. Thus, the expanded stent 20 frictionally engagesat least a portion of the native aortic valve 24. This substantiallyprevents axial movement of the prosthetic valve 14 and theballoon-expandable conduit 12 relative to the aortic valve 24.

The ring 34 extends around an outside (as shown in FIG. 2) or inside (asshown in FIG. 1) (or both) of the stent 20 and provides a structure forattachment and support of the valve leaflets 22. The ring 34 may beconstructed of a polymer, tightly woven cloth material, such as a PETfabric or a PTFE fabric. Sutures or stitches 36 may be used to attachthe cloth material ring 34 to the stent frame 20 by extending throughthe cloth material, over the stent frame on inside and outside surfacesand through the stent openings, as shown in FIG. 3. Additionally, thestitches 36 may attach the stent frame 20 and cloth ring 34 to thesleeve 18, whether the sleeve extends over the inside and/or outsidesurfaces of the stent frame.

The valve leaflets 22 are preferably constructed of a soft, pliablematerial such as thin bioprosthetic material, such as bovinepericardium. The valve leaflets are sewn, bonded or otherwise attachedto the cloth ring 34 around its inside surface to form a one-waytricuspid valve structure. In this manner, with the attachmentsdescribed above, the valve leaflets 22 are firmly anchored to the clothring 34 which is attached via stitches 36 or other means to the frame 20and the sleeve 18. This prosthetic heart valve 14 construction then, asdescribed herein, serves as the anchor for the remaining medical device10 and for the conduit 12.

The stitches 36 may be constructed of a heavy suture material for a firminterconnection of the above-listed components. Various stitches areshown herein including long axially-directed loops (FIG. 2) that extendover ends of the ring 34. Or, as shown in FIG. 4, alternating zig-zagstitches may pierce and extend through the ring 34. Generally, thestitching pattern may be adapted to suit the thickness of the materiallayers, geometry of the stent and other variations described herein.

The delivery device 16, as shown in FIG. 3, shows the assembled medicaldevice 10 ready for delivery of the conduit 12 and valve 14. Thedelivery device 16 includes the retractable outer sheath 32 and theballoon catheter 40 mounted within a central lumen of the outer sheath.The balloon catheter 40 includes a guide wire 42, an inflation catheter44 and the balloon 28.

The guide wire 42 is a semi-flexible wire that is placed through theskin and up through the aortic valve 24 and into the ascending aorta ina transapical approach, as shown in FIG. 4. Conversely, the guide wire42 may use a transfemoral approach by extending up the femoral arteryand down the aortic arch through the aortic valve 24. Alternativeapproaches may also be used, including a more direct transaorticapproach. Various approaches may or may not use a guide wire 42.Placement of the guide wire 42 may also use various devices such as anobturator to define gradually increasing diameter access holes, such asa transapical access hole.

The inflation catheter 44 defines a central lumen 46 by which it can besleeved over the guide wire 42 once the guide wire is in place. Theinflation catheter also includes an inflation lumen 48 which terminateswithin the walls of the balloon 28 mounted on the inflation catheter 44.At the proximal operator end, it may be attached to a gas or fluidsupply for inflation of the balloon 28 during the deployment procedure.Construction and use of a balloon inflation catheter are well known tothose of ordinary skill in the art.

The balloon 28, as shown in FIGS. 1 and 3, includes a balloon wall 50that is configured to form a toroid cylinder shape extending along anaxial portion of the inflation catheter 44. The balloon wall in FIG. 3is crimped against the inflation catheter 44 and extends under theconduit 12 but stops short of the prosthetic heart valve 14. The balloon28 may be directly beneath the frame 20 in some embodiments or may beunder the sleeve 18 when the sleeve extends inside the frame in otherembodiments, or in some combination of both.

The outer sheath 32 is another elongate, flexible tube that isconfigured to hold the expandable conduit 12 and the heart valve 14 inthe crimped condition, as shown in FIG. 3. The prosthetic heart valve 14extends around and is crimped onto the inflation catheter 44 notsupporting the balloon 28. The expandable conduit 12 is crimped over theportion supporting the balloon 28. The lack of the intervening balloon28 allows the leaflets 22 of the prosthetic heart valve to be compresseddirectly on the inflation catheter. This allows for a more uniform,smaller diameter of the medical device 10 in its crimped configuration.Smaller diameter delivery allows for use of the device 10 with a widerrange of patients and less invasive procedures.

In the crimped condition, the soft tissue of the bioprosthetic sleeve 18is notably bunched or crimped along the length of the delivery device16. The soft tissue is then smoothed out during inflation and plasticdeformation of the supporting frame or stent 20. Similarly, the valveleaflets 22 unfold or uncrimp, although under self-expansion by theshape memory effect of the supporting portion of the stent 20.

Also notable, is that the approach used for delivery may dictate whetherthe prosthetic heart valve is near the distal end of the outer sheath32, such as for a transfemoral approach, or may be on a more proximalend (relative to the expandable conduit 12) of the outer sleeve (asshown in FIGS. 1 and 4) for the transapical approach.

Also, the delivery device 16 may include the use of radiopaque markersfor targeting an aneurysm or the dilated portion of the diseased aortaor other vessel for easier implantation. Flush valves may also beincluded in the delivery device 16.

In addition, the retractable outer sheath 32 may include one or moreradiopaque markers 64 supported on an outer surface of the sheath, asshown in FIG. 1. These markers 64 are designed to help position thedelivery system and can be used to specifically position the system totarget an aneurysm or dilated portion of a diseased vessel.

The medical device 10 may have additional features to facilitate itsanchoring and later incorporation (by healing) into the surroundingtissue. For example, additional cloth PET portions could be used at theopposing ends extending around the outer frame 20 or sleeve 18.

The medical device 10 may also be stabilized by a plurality of metalanchors 52, as shown in FIGS. 1 and 4. The anchors 52 may extendradially about 2 mm to about 4 mm from the outer surface of the conduit12 and/or the prosthetic heart valve 14. In addition, the anchors 52 maybe circumferentially spaced apart along the length of the expandableconduit 12 or heart valve 14. In other embodiments, one or more anchors52 may be defined on the frame or stent 20. Or the anchors may extendfrom the bioprosthetic sleeve 18.

The anchors may be constructed of a range of biocompatible materials,such as stainless steel, Nitinol or polymeric materials.

FIGS. 5-8 illustrate various embodiments of the anchors 52. As shown inFIG. 5, the anchor 52 includes a base 54 topped by an irritation bead 56defining a dimple 58. The base 54 is attached to the stent frame 20 (asshown) or directly to the sleeve 18. The irritation bead 56 is aspherical structure formed on or bonded to the base 54. It functions toirritate the surrounding tissue and induce a growth response to helpanchor the conduit 12. The dimple 58 is a small golf-ball-like recessthat further enhances irritation and tissue ingrowth.

As shown in FIG. 6, the anchors 52 may include a base 54 that supports adiscrete field of fenestrations 60 that extend radially outward. Thefenestrations 60 are configured to frictionally engage tissue of thenative vessel. These fenestrations, for example, may be formed as aknurled crisscross patterns of pyramidal structures by cold rolling themetal from which the anchors 52 are cut.

As shown in FIGS. 7 and 8, the anchors 52 may include a base 54 thatsupports a disc-shaped protrusion 62. The disc shape has a top surfacethat extends in the axial direction of the underlying frame 20. Thediameter of the disc protrusion 62 is larger than the supporting base54. This shape facilitates its anchoring on the tissue walls. The tissuebecomes lodged under the disc 62, between it and the base 54 orunderlying conduit 12.

In another embodiment, each of the anchors 52 may include a plurality ofarms that extend outwards and are configured to frictionally engage thesurrounding tissue.

A method of construction of the expandable conduit 12 and the prostheticheart valve 14 may include coating or covering the interior surface,exterior surface, or both of the frame or stent 20 with (1) abioprosthetic tissue, which may be selected from the group comprising abovine pericardium, porcine pericardium, and allogenic/autogeniccollagen matrix tissue, (2) a polymer, (3) a gel applied to a substrateor (4) a cloth, such as PTFE or Dacron, to form the sleeve 18. Thesleeve 18, if it has a biological component, may then be glycerolized tofacilitate dry storage. The method may also include applying a covering,such as a cloth, and coating the covering with a gel or polymer to formmultiple layers.

During assembly of the medical device 10, the expandable conduit 12 issleeved over the inflation catheter 44 until over the balloon 28. Theprosthetic heart valve 14 is also sleeved (as the expandable conduit 12is sleeved) over the adjacent portion of the inflation catheter 44without the balloon. The prosthetic heart valve 14 is in the expandedcondition due to its shape memory properties while the expandableconduit 12 is still relatively compact. A crimper is then used to crimpthe conduit and valve, and underlying balloon 28, which are insertedinto the outer, retractable sleeve 32 of the delivery device 16.

During delivery, the guide wire 42 is placed through the transapical ortransfemoral approaches, as described above, until part of the wireextends through the aortic arch 26 and part of the wire through thenative heart valve 24. Some preliminary balloon expansion may beperformed to open the calcified native heart valve.

The balloon catheter 40 is then sleeved over the guide wire and into thenative heart valve 24 and aortic arch 26. The outer sheath 32 iswithdrawn to allow the prosthetic heart valve 14 to expand into andcompress the native heart valve 24, as shown in FIG. 4. The inflationlumen 48 of the inflation catheter 44 is used to pump saline or otherfluid into the balloon 28, expanding the balloon wall 50 and surroundingconduit 12, as shown in FIG. 1. The anchors 52 impinge upon or engagethe surrounding vessel and anchor thereto.

Advantageously, the medical device 10 described above can achieve asmaller compressed diameter to facilitate minimally invasive delivery ofa prosthetic heart valve together with an attached conduit.

What is claimed is:
 1. A system for use in replacing a native aorticheart valve of a human and repairing a defect in a section of the aortacontiguous with the native aortic heart valve, the system comprising: acatheter having a balloon thereon; a retractable sheath defining aninterior portion; a medical device sleeved over the catheter, themedical device having a length sufficient to extend from a first endconfigured to be secured at the native aortic heart valve to a secondend configured to be attached within and extending along the aorta atleast as far as the aortic arch, the medical device comprising: aself-expandable prosthetic valve located at the first end compressedradially inwardly and held in a delivery state within the interiorportion of the retractable sheath and configured to expand in a radiallyoutward direction to frictionally engage at least a portion of thenative heart valve; an aortic conduit comprising a balloon-expandabletubular frame and a tubular sleeve extending axially along and againstthe balloon-expandable frame, the aortic conduit being coupled to an endof the prosthetic valve and crimped around the balloon, the balloonextending along the conduit but not within the prosthetic valve.
 2. Thesystem of claim 1, wherein the balloon-expandable tubular framecomprises a plastically deformable metal material.
 3. The system ofclaim 1, wherein prosthetic valve includes a self-expandable stent andflexible valve leaflets supported within the self-expandable stent. 4.The system of claim 3, wherein the balloon-expandable tubular frame andself-expandable stent are a single stent contiguously formed of aNitinol alloy.
 5. The system of claim 3, wherein the prosthetic valvefurther comprises an annular ring of a woven material coupling the valveleaflets to the self-expandable stent.
 6. The system of claim 5, furtherincluding an outer tubular sleeve extending axially along and outside ofthe balloon-expandable tubular frame to provide a tubular surfacebetween the aortic conduit and surrounding native tissue.
 7. The systemof claim 1, wherein the tubular sleeve is an inner tubular sleeve thatextends axially along and within the balloon-expandable tubular frame toprovide a tubular barrier between the balloon-expandable conduit andblood flowing through the aortic conduit.
 8. The system of claim 1,wherein the tubular sleeve comprises a collagen gel absorbed into awoven polyester substrate.
 9. The system of claim 1, wherein the tubularsleeve comprises bioprosthetic tissue selected from a group consistingof a bovine pericardium, a porcine pericardium, and anallogenic/autogenic collagen matrix tissue.
 10. The system of claim 9,wherein the bioprosthetic tissue is glycerolized to facilitate drystorage.
 11. The system of claim 1, further comprising one or moreanchors that are circumferentially spaced apart about an outer surfaceof the medical device and extend radially outwardly to facilitateattachment to surrounding tissue.
 12. A system for use in replacing anative aortic heart valve of a human and repairing a defect in a sectionof the aorta contiguous with the native aortic heart valve, the systemcomprising: a catheter having a balloon thereon; a retractable sheathdefining an interior portion; a medical device sleeved over the catheterhaving a length sufficient to extend from a first end configured to besecured at the native aortic heart valve to a second end configured tobe attached within and extending along the aorta at least as far as theaortic arch, the medical device comprising: a prosthetic valvecomprising a self-expandable stent and located at the first end, theprosthetic valve compressed radially inwardly and held in a deliverystate by the retractable sheath and configured to expand in a radiallyoutward direction to frictionally engage at least a portion of thenative heart valve; an aortic conduit comprising a balloon-expandabletubular frame and a tubular sleeve extending axially along and againstthe balloon-expandable frame, wherein the tubular frame and theself-expandable stent are a single stent contiguously formed of aNitinol alloy, the aortic conduit being coupled to an end of theprosthetic valve and crimped around the balloon, the balloon extendingalong the conduit but not within the prosthetic valve.
 13. The system ofclaim 12, wherein prosthetic valve includes flexible valve leafletssupported within the self-expandable stent.
 14. The system of claim 13,wherein the prosthetic valve further comprises an annular ring of awoven material coupling the valve leaflets to the self-expandable stent.15. The system of claim 12, wherein the tubular sleeve is an innertubular sleeve that extends axially along and within theballoon-expandable tubular frame to provide a tubular barrier betweenthe balloon-expandable conduit and blood flowing through the aorticconduit.
 16. The system of claim 15, further including an outer tubularsleeve extending axially along and outside of the balloon-expandabletubular frame to provide a tubular surface between the aortic conduitand surrounding native tissue.
 17. The system of claim 12, wherein thetubular sleeve comprises a collagen gel absorbed into a woven polyestersubstrate.
 18. The system of claim 12, wherein the tubular sleevecomprises bioprosthetic tissue selected from a group consisting of abovine pericardium, a porcine pericardium, and an allogenic/autogeniccollagen matrix tissue.
 19. The system of claim 18, wherein thebioprosthetic tissue is glycerolized to facilitate dry storage.
 20. Thesystem of claim 12, further comprising one or more anchors that arecircumferentially spaced apart about an outer surface of the medicaldevice and extend radially outwardly to facilitate attachment tosurrounding tissue.